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The purpose of this study is to determine whether gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn is effective in the treatment of neuropathic pain associated with diabetic peripheral neuropathy(DPN)
This is a dose-response study of XP13512 compared with concurrent placebo control and LYRICA (pregabalin), in subjects with neuropathic pain associated with DPN. Three doses of XP13512 (1200 mg/day, 2400 mg/day and 3600 mg/day) are being evaluated for the management of neuropathic pain associated with DPN. Approximately 392 subjects from 70 to 80 participating sites in the US will be randomized to receive either XP13512 at the above mentioned doses, placebo or pregabalin (300mg/day).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Pregabalin | Other | Pregabalin 300mg/day (positive control), maintenance treatment 14 weeks |
|
| GEn 1200mg/day | Experimental | gabapentin enacarbil 1200mg/day, maintenance treatment 14 weeks |
|
| GEn 2400mg/day | Experimental | gabapentin enacarbil 2400mg/day, maintenance treatment 14 weeks |
|
| GEn 3600mg/day | Experimental | gabapentin enacarbil 3600mg/day, maintanance treatment 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo |
| |
| GEn 1200mg/day |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alabaster | Alabama | 35007 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23186035 | Derived | Rauck R, Makumi CW, Schwartz S, Graff O, Meno-Tetang G, Bell CF, Kavanagh ST, McClung CL. A randomized, controlled trial of gabapentin enacarbil in subjects with neuropathic pain associated with diabetic peripheral neuropathy. Pain Pract. 2013 Jul;13(6):485-96. doi: 10.1111/papr.12014. Epub 2012 Nov 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening). |
| FG001 | GEn 1200 mg/Day |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
gabapentin enacarbil 1200mg/day |
|
|
| GEn 2400mg/day | Drug | gabapentin enacarbil 2400mg/day |
|
|
| GEn 3600mg/day | Drug | gabapentin enacarbil 3600mg/day |
|
|
| Pregabalin | Drug | pregabalin 300mg/day |
|
| Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data | Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data | Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data | Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data | Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data | The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data | The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT | Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data | The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit. | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data | The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit. | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score | Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization. | Any time post-baseline until date of last dose of study medication (up to Week 13) |
| Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data | The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | Baseline and EOMT |
| Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data | The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data | The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| GSK Investigational Site | Dothan | Alabama | 36303 | United States |
| GSK Investigational Site | Hoover | Alabama | 35216 | United States |
| GSK Investigational Site | Jasper | Alabama | 35501 | United States |
| GSK Investigational Site | Muscle Shoals | Alabama | 35662 | United States |
| GSK Investigational Site | Northport | Alabama | 35476 | United States |
| GSK Investigational Site | Tuscaloosa | Alabama | 35406 | United States |
| GSK Investigational Site | Mesa | Arizona | 85210 | United States |
| GSK Investigational Site | Peoria | Arizona | 85381 - 4828 | United States |
| GSK Investigational Site | Tempe | Arizona | 85282 | United States |
| GSK Investigational Site | Hot Springs | Arkansas | 71901 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | Anaheim | California | 92801 | United States |
| GSK Investigational Site | Concord | California | 94520 | United States |
| GSK Investigational Site | Escondido | California | 92026 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Huntington Park | California | 90255 | United States |
| GSK Investigational Site | La Jolla | California | 92037 | United States |
| GSK Investigational Site | Los Gatos | California | 95032 | United States |
| GSK Investigational Site | Mission Viejo | California | 92691 | United States |
| GSK Investigational Site | Newport Beach | California | 92660 | United States |
| GSK Investigational Site | Northridge | California | 91325 | United States |
| GSK Investigational Site | Oxnard | California | 93030 | United States |
| GSK Investigational Site | Riverside | California | 92506 | United States |
| GSK Investigational Site | San Diego | California | 92117 | United States |
| GSK Investigational Site | Santa Ana | California | 92705 | United States |
| GSK Investigational Site | Santa Monica | California | 90404 | United States |
| GSK Investigational Site | Temecula | California | 92591 | United States |
| GSK Investigational Site | Walnut Creek | California | 94598 | United States |
| GSK Investigational Site | Westlake Village | California | 91361 | United States |
| GSK Investigational Site | Brandon | Florida | 33511 | United States |
| GSK Investigational Site | Clearwater | Florida | 33765 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33308 | United States |
| GSK Investigational Site | Fort Myers | Florida | 33916 | United States |
| GSK Investigational Site | Hallandale | Florida | 33009 | United States |
| GSK Investigational Site | Hollywood | Florida | 33021 | United States |
| GSK Investigational Site | New Port Richey | Florida | 34652 | United States |
| GSK Investigational Site | Ocala | Florida | 34471 | United States |
| GSK Investigational Site | Ormond Beach | Florida | 32174 | United States |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | United States |
| GSK Investigational Site | St. Petersburg | Florida | 33702 | United States |
| GSK Investigational Site | Tallahassee | Florida | 32308 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30308 | United States |
| GSK Investigational Site | Decatur | Georgia | 30033 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Roswell | Georgia | 30076 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Libertyville | Illinois | 60048 | United States |
| GSK Investigational Site | Evansville | Indiana | 47713 | United States |
| GSK Investigational Site | Evansville | Indiana | 47714 | United States |
| GSK Investigational Site | Wichita | Kansas | 67207 | United States |
| GSK Investigational Site | Rockville | Maryland | 20852 | United States |
| GSK Investigational Site | Wellesley Hills | Massachusetts | 02481 | United States |
| GSK Investigational Site | Kalamazoo | Michigan | 49048 | United States |
| GSK Investigational Site | Olive Branch | Mississippi | 38654 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | St Louis | Missouri | 63117 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89016 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| GSK Investigational Site | Flushing | New York | 11365 | United States |
| GSK Investigational Site | New York | New York | 10128 | United States |
| GSK Investigational Site | North Massapequa | New York | 11758 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Staten Island | New York | 10301 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27408 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27607 | United States |
| GSK Investigational Site | Salisbury | North Carolina | 28144 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Norman | Oklahoma | 73071 | United States |
| GSK Investigational Site | Eugene | Oregon | 97404 | United States |
| GSK Investigational Site | Medford | Oregon | 97501 | United States |
| GSK Investigational Site | Levittown | Pennsylvania | 19056 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15243 | United States |
| GSK Investigational Site | Greer | South Carolina | 29651 | United States |
| GSK Investigational Site | Mt. Pleasant | South Carolina | 29464 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | San Antonio | Texas | 78238 | United States |
| GSK Investigational Site | Alexandria | Virginia | 22311 | United States |
| GSK Investigational Site | Richmond | Virginia | 23249 | United States |
| GSK Investigational Site | Weber City | Virginia | 24290 | United States |
| GSK Investigational Site | Spokane | Washington | 99202 | United States |
| GSK Investigational Site | Spokane | Washington | 99208 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Vancouver | Washington | 98664 | United States |
One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| FG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| FG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| FG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
| Safety Population/Treated With Drug |
|
| ITT Population |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening). |
| BG001 | GEn 1200 mg/Day | One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| BG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| BG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| BG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age in years of the Intent-to-Treat (ITT) Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics. This population does not include all participants randomized to study treatment. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Gender of the ITT Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics. This population does not include all participants randomized to study treatment. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Race of the ITT Population, comprised of all randomized participants who took at least one dose of investigational product and provided at least one post-baseline efficacy measurement, was used for all baseline characteristics. This population does not include all participants randomized to study treatment. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Mean 24-hour Average Pain Intensity (API) Score at End of Maintenance Treatment (EOMT) Using Last Observation Carried Forward (LOCF) Data | Baseline and EOMT values are the calculated means of the daily 24-hour API scores for each participant during the last 7 days prior to randomization (Baseline) and the earliest date of Week 13 visit/Withdrawal visit/last dose of study drug (EOMT). Participants used a hand-held diary to rate their API over the preceding 24 hours, using an 11-point Pain Intensity Numerical Rating Scale (PI-NRS) (0=no pain, 10=pain as bad as you can imagine). LOCF was used if less than 4 days of diary data were provided. Change from baseline was calculated as the EOMT score minus the Baseline score. | ITT Population | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
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| Secondary | Change From Baseline in the Mean Day-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Day-time is defined as the time between rising in the morning and going to bed at night. Participants recorded day-time API on a daily basis in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean Night-time Average Pain Intensity (API) Score at EOMT Using LOCF Data | Night-time is defined as the time between going to bed at night and rising in the morning. Participants recorded night-time API on a daily basis in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate an average night-time pain intensity score for the EOMT timepoint. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
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| Secondary | Change From Baseline in the Mean Current (Morning) Pain Intensity Score at EOMT Using LOCF Data | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current morning pain intensity in the morning upon wakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a current (morning) pain intensity score for the EOMT timepoint. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
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| Secondary | Change From Baseline in the Mean Current (Evening) Pain Intensity Score at EOMT Using LOCF Data | Current pain is defined as the participant's assessment of pain intensity "right now." Participants recorded their current evening pain intensity in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean Day-time Worst Pain Intensity Score at EOMT Using LOCF Data | Day-time worst pain is defined as the partipant's assessment of their worst pain between rising in the morning and going to bed at night. Participants recorded day-time worst pain in the evening before bedtime using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean Night-time Worst Pain Intensity Score at EOMT Using LOCF Data | Night-time worst pain is defined as the partipant's assessment of their worst pain between going to bed at night and rising in the morning. Participants recorded night-time worst pain in the morning upon awakening using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Mean Sleep Interference Score at EOMT Using LOCF Data | Participants assessed sleep interference due to pain on a daily basis in the morning upon awakening using an 11-point NRS (0=pain does not interfere with sleep, 10=pain completely interferes with sleep). Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population. There were two participants in the GEn 3600 mg/day group who did not complete enough post-baseline morning diaries to calculate a night-time worst pain intensity score for the EOMT timepoint. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
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| Secondary | Change From Baseline in the Mean Daily Dose of Rescue Medication at EOMT Using LOCF Data | Mean daily use of rescue medication (milligrams of acetaminophen) was calculated by determining the average number of tablets taken per day of rescue medication (Commerical Tylenol) during treatment and multiplying that by 500 mg. Baseline and EOMT are as defined for the primary endpoint. Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with baseline value, BMI, grouped center as covariates was used. | ITT Population | Posted | Least Squares Mean | Standard Error | milligrams | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Quality as Assessed by the Neuropathic Pain Scale (NPS) Summary Scores at EOMT Using LOCF Data | The NPS assesses pain qualities and consists of 11-items, 10 assessed on an 11-point NRS (0=no impact to 10=greatest impact); and 1 open-ended question not used in score calculation. 4 summary scores are calculated: NPS 10 (items 1-7, 9-11), NPS 8 (8 pain descriptor items), NPS Non-Allodynic (NA) (8 NA items), and NPS 4 (4 pain quality items); and range from 0 to 100 (0=no impact and 100=greatest impact). The analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | ITT Population. Not all participants completed an NPS assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Characteristics and Intensity as Assessed by the Short Form-McGill Pain Questionnaire (SF-MPQ) at EOMT Using LOCF Data | The SF-MPQ, a general pain instrument, assesses the characteristics and intensity of pain and consists of 15-items assessed on a 4-point scale (0=none, 1=mild, 2=moderate, and 3=severe). 3 summary scores are calculated: sensory score (sum of items 1-11, range 0-33), affective score (sum of items 12-15, range 0-12), total score (sum of items 1-15, range 0-45), where lower scores = lower pain/impact. Analysis is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | ITT Population. Not all participants completed an SF-MPQ assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Score After Taking a 50-foot Walk at EOMT | Baseline and EOMT scores are the pain scores each participant reported after taking a 50-foot walk at the randomization and Week 13/Withdrawal visits, respectively, using an 11-point PI-NRS (0=no pain, 10=pain as bad as you can imagine). Change from baseline was calculated as the EOMT score minus the baseline score. An ANCOVA model with BMI, baseline pain intensity after 50-foot walk, pain intensity prior to 50-foot walk at the visit being assessed, and grouped center as covariates was used. | ITT Population. Not all participants completed a 50-foot walk at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Are Responders on the Patient Global Impression of Change (PGIC) Questionnaire at EOMT Using LOCF Data | The PGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the participant's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit. | ITT Population. Not all participants completed a PGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Number | participants | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Are Responders on the Clinician Global Impression of Change (CGIC) Questionnaire at EOMT Using LOCF Data | The CGIC is a single-item questionnaire designed to provide an overall assessment of treatment from the clinician's perspective since the start of the study. It is measured on a 7-point scale, where 1=very much improved and 7=very much worse. A participant is considered a responder if they have a response of "very much improved" or "much improved." EOMT response is defined as the score recorded at the Week 13/Withdrawal visit. | ITT Population. Not all participants had a CGIC assessment at Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Number | participants | EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Achieving Various Levels of Percent Reduction From Baseline in the Mean 24-hour Average Pain Intensity Score at EOMT Using LOCF Data | Baseline and EOMT scores are the calculated means of the 24-hour average pain scores for each participant during the last 7 days prior to randomization and EOMT, respectively. Percent reduction from baseline was calculated as the [(EOMT score minus the baseline score)divided by the baseline score], multiplied by 100. The PI-NRS is an 11-point scale (0=no pain, 10=pain as bad as you can imagine) by which a participant assesses their 24-hour average pain intensity. | ITT Population | Posted | Number | participants | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Onset of Sustained Improvement in the 24-hour Average Pain Intensity Score | Sustained improvement in the 24-hour average pain intensity score is defined as at least 2 consecutive days on which the 24-hour average pain intensity score is >=2 points less than the mean 24-hour average pain intensity score at baseline. Time to onset is measured from baseline and was calculated as first day of event minus last day of baseline and is expressed in days. Baseline score is the calculated mean of the 24-hour average pain score for each participant during the last 7 days prior to randomization. | ITT Population | Posted | Median | Full Range | days | Any time post-baseline until date of last dose of study medication (up to Week 13) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Severity of Pain and the Impact of Pain as Assessed by the Brief Pain Inventory (BPI) at EOMT Using LOCF Data | The BPI, a general pain instrument, assesses the severity and interference of pain; and consists of 6 items assessed on an 11-point NRS (0=no impact and 10=greatest impact). 2 summary scores are calculated: BPI Severity Score (average of first 4 items) and BPI Interference Score (average of 7 responses to item 6); where each summary score ranges from 0 to 10 (0=no impact and 10=greatest impact). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | ITT Population. Not all participants completed a BPI assessment at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) at EOMT Using LOCF Data | The SF-36 is a general health-related quality of life instrument consisting of 36 items with various response options (Yes/No, 5- to 6-point Likert scale). Summary scores are calculated for 8 domains and 2 components (physical and mental); where scores range from 0 to 100 (higher scores = better quality of life). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | ITT Population. Not all participants completed an SF-36 at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
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| Secondary | Change From Baseline in Emotional Functioning as Assessed by the Profile of Mood States-Brief Form (POMS-B) at EOMT Using LOCF Data | The POMS-B, an emotional functioning instrument, assesses mood, tension, and other psychological symptoms and consists of 30-items assessed on a 5-point scale (0=not at all to 4=extremely). 6 summary scores are calculated: Tension/Anxiety, Depression/Rejection, Anger/Hostility, Vigor/Activity, Fatigue/Inertia, and Confusion/Bewilderment; and range from 0-20 (higher scores = more negative mood state). Analysis of this endpoint is based on the change from baseline (BL) (EOMT score minus the BL score) using an ANCOVA model with BL value, BMI, grouped center as covariates. | ITT Population. Not all participants completed a POMS-B at both Baseline and Week 13/Withdrawal; as such, the number analyzed is different from the full ITT Population counts. | Posted | Least Squares Mean | Standard Error | scores on a scale | Baseline and EOMT (representing the earliest date of Week 13 visit/withdrawal visit) |
|
Not provided
Adverse events (AEs) and serious adverse events (SAEs) were captured for all participants in the Safety Population, comprised of all randomized participants who took at least one dose of investigational product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening); one 100 mg pregabalin (PGB) placebo capsule taken orally three times daily (morning, midday, and evening). | 6 | 120 | 50 | 120 | ||
| EG001 | GEn 1200 mg/Day | One 600 mg extended release (ER) GEn tablet and two 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). | 3 | 62 | 34 | 62 | ||
| EG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). | 4 | 56 | 25 | 56 | ||
| EG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). | 5 | 116 | 62 | 116 | ||
| EG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). | 2 | 66 | 32 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Partial seizures | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Chronic lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Affective disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| XenoPort Call Center | XenoPort, Inc. | 877-936-6778 |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C493250 | 1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
| Male |
|
| American Indian or Alaskan Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| Not Provided |
|
|
| ANCOVA |
An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used. |
| 0.946 |
This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05. |
| Adjusted mean difference versus placebo |
| -0.02 |
| 95 |
| -0.71 |
| 0.66 |
| No |
| Superiority or Other |
| ANCOVA | An ANCOVA model with BMI, baseline 24-hour average pain intensity, and grouped center as covariates was used. | 0.105 | This p-value has been adjusted for multiplicity using a combination of a sequential method and the Hochberg procedure in order to maintain the overall experiment-wise alpha level of 0.05. | Adjusted mean difference versus placebo | -0.55 | 95 | -1.10 | 0.01 | No | Superiority or Other |
| Adjusted mean difference versus placebo | 0.43 | 95 | -0.22 | 1.08 | No | Superiority or Other |
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| GEn 2400 mg/Day |
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 |
| GEn 2400 mg/Day |
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 |
| GEn 2400 mg/Day |
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| GEn 2400 mg/Day |
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
|
|
| OG002 | GEn 2400 mg/Day | Two 600 mg ER GEn tablets and one 600 mg GEn placebo tablet taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG003 | GEn 3600 mg/Day | Three 600 mg ER GEn tablets taken orally twice daily (morning and evening); one 100 mg PGB placebo capsule taken orally three times daily (morning, midday, and evening). |
| OG004 | PGB 300 mg/Day | Three 600 mg GEn placebo tablets taken orally twice daily (morning and evening); one 100 mg PGB capsule taken orally three times daily (morning, midday, and evening). |
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